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Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Analysis was performed on the Total Vaccinated cohort on subjects with available results

Reporting Groups

Description

Boostrix Group

Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)

Decavac Group

Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)

Measured Values

Boostrix Group

Decavac Group

Participants Analyzed [Units: Participants]

882

445

Number of Subjects Reporting Solicited General Symptoms [Units: Subjects]

Fatigue

110

66

Gastrointestinal symptoms

67

41

Headache

101

52

Fever

18

11

No statistical analysis provided for Number of Subjects Reporting Solicited General Symptoms

9. Secondary:

Number of Subjects Reporting Unsolicited Adverse Events (AE) [ Time Frame: Within the 31-day (Day 0-30) post-vaccination period ]